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Completed

NCT Number: NCT07327671

Positioning Device for Female Urinary Catheterization

In female patients, the dorsal recumbent position is required to visualize the urethral meatus. In female patients, direct visualization of the urethral meatus after providing a suitable position is very important for successful catheter advancement while maintaining sterile conditions. Especially in unconscious or uncooperative female patients, it is much more difficult to maintain and maintain an appropriate position, and more than one staff may be needed for this. Although it is clear that it is important and difficult to position female patients during catheterization and maintain it throughout the procedure, no device used to assist positioning has been encountered. Therefore, in this project; The aim of this study is to provide a comfortable and safe position for the patient in urinary catheterization in female patients, to develop an auxiliary device to maintain this position throughout the procedure, and to evaluate the effectiveness of this device.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Turkey, Gulhane Faculty of Nursing, Ankara, Turkey

Ankara, Turkey (Türkiye)

About this study

Urinary elimination is one of the most fundamental physiological needs, and when it cannot be met by the individual for any reason, urinary catheterisation is required to drain urine accumulated in the bladder. Urinary catheterisation consists of a series of sequential steps. The first step is positioning the patient. In female patients, the dorsal recumbent position is required to visualise the urethral meatus. Once an appropriate position has been achieved in female patients, direct visualisation of the urethral meatus is crucial for the successful advancement of the catheter under sterile conditions. Providing and maintaining an appropriate position is particularly difficult in unconscious or uncooperative female patients, and may require multiple personnel. Although it is clear that positioning female patients during catheterisation and maintaining this position throughout the procedure is important and difficult, no devices have been found to assist with positioning. Therefore, this project aims to develop an assistive device to provide female patients with a comfortable and safe position during urinary catheterisation and to maintain this position throughout the procedure, and to evaluate the effectiveness of this device. To this end, a new positioning cushion will be developed, and a preclinical validation study will be conducted using a mixed-methods research design that includes a randomised controlled trial and a descriptive qualitative study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a nurse with at least a bachelor's degree
  • Previous experience of urinary catheterization
  • Having worked or working in intensive care
  • Having voluntarily agreed to participate in the research

Exclusion criteria

  • Leaving work voluntarily

Treatment and study plan

dorsal recumbent positioning device

Device

Participants in the supine positioning device group use this device prior to the procedure to ensure the supine position during urinary catheterisation in female patients. Once this device has safely secured the position, the steps for urinary catheterisation are carried out.

Primary outcomes

  1. Urinary Catheterization Procedure Time (minutes)

    Time frame: From the start to the end of the catheterisation procedure, a maximum of 10 minutes

    Total time required to complete the urinary catheterization procedure, measured in minutes from video recordings, including preparation time, catheter insertion time, and total procedure duration.

  2. Nurses' Lumbar Fatigue (Visual Analog Scale, VAS 0-100)

    Time frame: Day 1

    Lower back fatigue experienced by nurses during the procedure, assessed using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater fatigue.

  3. Need for Support Personnel

    Time frame: Day 1

    Requirement for additional support staff during the procedure, recorded as yes/no based on video analysis.

  4. Nurses' Physical Effort (Visual Analog Scale, VAS 0-100)

    Time frame: Day 1

    Physical effort perceived by nurses during the catheterization procedure, measured using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater physical effort.

Secondary outcomes

  1. User Satisfaction (QUEST 2.0)

    Time frame: Day 1

    Satisfaction with the dorsal recumbent positioning device measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Developing and Efficiency Evaluation of a Positioning Assist Device for Urinary Catheterization in Female Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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